Oridion Capnostream 20p User manual

Capnostream

®

20

p

Portable Bedside Monitor

Capnograph/Pulse Oximeter

Operator’s Manual

PN: 012194C

0482

Notice: Purchase of this product confers no express or implied license under any Oridion Medical 1987 Ltd.

patent to use the instrument with any accessory that is not manufactured or licensed by Oridion Medical 1987

Ltd.

Possession or purchase of this device does not convey an express or implied license to use the device with

unauthorized sensors or cables which would, alone, or in combination with this device, fall within the scope of

one or more of the patents relating to this device.

Oridion

®

, Microstream

®

, FilterLine, Smart CapnoLine

®

, CapnoLine

®

, Smart BiteBloc™, NIV Line™,

CapnoBloc™, Smart CapnoLine Guardian™, SARA™, Integrated Pulmonary Index™, Capnostream

®

20

p

,

Microcap

®

, Microcap

®

Plus, and VitalCap

®

are trademarks or registered trademarks of Oridion Medical 1987

Ltd.

Nellcor Puritan Bennett LLC is a Covidien company.

The following are trademarks of Nellcor Puritan Bennett LLC: Oxiband™; Durasensor™; OxiCliq

®

; Dura-Y

™

;

Max-Fast™ and O

XIMAX™.

The capnography component of this product is covered by: US Patents: www.covidien.com/patents.

The pulse oximetry component of this product is covered by: US Patents: www.covidien.com/patents.

Exemptions

Oridion Medical 1987 Ltd.'s liability under this warranty does not include any transportation damage or other

charges or liability for direct, indirect or consequential damages or delay resulting from improper use or

application of the product or the substitution upon it of parts or accessories not approved by Oridion Medical

1987 Ltd.

All information in this manual is believed to be correct. Oridion Medical 1987 Ltd. shall not be liable for errors

contained herein with the performance or use of this manual.

Portable Bedside Capnograph/Pulse Oximeter

1

Table of Contents

Table of Contents 1

List of Figures 8

List of Tables 9

Oridion Medical 1987 Ltd. ("Oridion Medical") - Warranty for

Oridion Monitors 10

Safety Information 11

Warnings ....................................................................................................................... 11

General ....................................................................................................................................... 11

MRI Scanning ............................................................................................................................. 12

Monitor Use with Defibrillators ................................................................................................... 12

Alarms ........................................................................................................................................ 12

Fire Hazard................................................................................................................................. 12

Electrical ..................................................................................................................................... 13

Electro-magnetic Interference .................................................................................................... 13

Definitions ..................................................................................................................... 14

Chapter 1 15

About this Manual 15

Overview ....................................................................................................................... 15

Intended Use ................................................................................................................. 15

Specific Indications for Use ........................................................................................... 16

Who Should Read This Manual ..................................................................................... 16

Contacting Technical Support ....................................................................................... 16

Symbols ........................................................................................................................ 16

Chapter 2 19

Technology Overview 19

Introduction ................................................................................................................... 19

Features ........................................................................................................................ 19

Technology Overview .................................................................................................... 19

What is Capnography? .............................................................................................................. 19

What is Pulse Oximetry? ............................................................................................................ 20

Chapter 3 21

The Capnostream Monitor 21

Unpacking and Inspection ............................................................................................. 21

Installing the Battery Pack ............................................................................................. 22

Testing the Battery and AC Connections................................................................................... 23

Handling the Battery Pack ......................................................................................................... 23

2

Portable Bedside Capnograph/Pulse Oximeter

Storing the Battery ..................................................................................................................... 24

Disposing of the Battery ............................................................................................................. 24

Battery and Power Usage .......................................................................................................... 24

Mounting the Monitor..................................................................................................... 25

Setting up Periodic Maintenance ................................................................................... 25

Accessories ................................................................................................................... 25

Available Accessories ................................................................................................................ 25

Monitor Mounting Plate .............................................................................................................. 26

Printer Paper .............................................................................................................................. 26

Buttons, Indicators and Connections ............................................................................. 26

Monitor Front View ..................................................................................................................... 27

Front Panel Control Buttons .......................................................................................... 28

Monitor Rear Panel .................................................................................................................... 29

Monitor Left and Right Views ..................................................................................................... 30

Turning on the Monitor .................................................................................................. 30

Standard Sections of the Display Screen ...................................................................... 31

Home Screen Standard Display ................................................................................................. 32

Home Screen Numeric Display .................................................................................................. 36

Terminating Operation of the Monitor ............................................................................ 37

Screen Navigation ......................................................................................................... 37

Configuration Changes .............................................................................................................. 38

Setting Date, Time, Language, and Other Options ....................................................... 38

Screen Timeouts ........................................................................................................... 39

Screen Timeouts ........................................................................................................................ 39

Capnostream

®

20

p

: Operational Check Sheet ................................................................ 40

Chapter 4 43

Using the Capnostream Monitor 43

Preparing the Monitor for a Patient ............................................................................... 43

Setting the Patient Type ............................................................................................................. 43

Using Patient Cases and Patient ID Numbers ............................................................... 44

Entering Patient Events ................................................................................................. 46

Changing the Alarm and Pulse Volumes ....................................................................... 46

Alarm Volume ............................................................................................................................. 46

Pulse Tone Volume .................................................................................................................... 47

Alarm Volume Default Options ................................................................................................... 47

Alarm Delay ................................................................................................................... 48

Use of Scavenging System ........................................................................................... 48

Turning the Pump Off for Suction or Lavage ................................................................. 48

Demo Mode ................................................................................................................... 49

Monitor Screen Menu Reference Chart ......................................................................... 49

Portable Bedside Capnograph/Pulse Oximeter

3

Chapter 5 53

Capnography with the Capnostream Monitor 53

Microstream

®

EtCO

2

Consumables ............................................................................... 53

Basic Principles .......................................................................................................................... 53

Microstream

®

EtCO

2

Consumables ........................................................................................... 54

Connecting a FilterLine ................................................................................................. 54

CO

2

Data Displayed by the Capnostream Monitor ........................................................ 54

Adjustable CO

2

Parameters .......................................................................................... 55

Monitoring CO

2

during MRI Scanning ........................................................................... 56

Chapter 6 57

Pulse Oximetry with the Capnostream Monitor 57

Nellcor SpO

2

Sensors ................................................................................................... 57

Data Update Period, Data Averaging, and Signal Processing .................................................. 58

Selecting Nellcor SpO

2

Sensors ................................................................................................ 58

Performance Considerations ..................................................................................................... 59

Connecting an SpO

2

Sensor to the Monitor................................................................... 60

SpO

2

Data Displayed by the Capnostream Monitor ...................................................... 60

Adjustable SpO

2

Parameters......................................................................................... 62

SPO

2

Alarm Limit Message ........................................................................................... 62

Chapter 7 63

Integrated Pulmonary Index™ 63

Introduction ................................................................................................................... 63

Warnings ....................................................................................................................... 64

IPI Display ..................................................................................................................... 64

IPI Options .................................................................................................................... 64

Chapter 8 65

Apneas per Hour and the Oxygen Desaturation Index 65

Introduction ................................................................................................................... 65

Apneas per Hour ........................................................................................................... 65

The Capnostream Apneas per Hour .......................................................................................... 65

A/hr Visual Alert ......................................................................................................................... 66

Oxygen Desaturation Index (ODI) ................................................................................. 66

Apnea and O2 Desaturation Report .............................................................................. 66

Monitoring with A/hr and ODI ........................................................................................ 66

Smart A/hr and ODI Home Screen Display ................................................................... 67

A/hr and ODI Option ...................................................................................................... 67

A/hr and ODI Demo Mode ............................................................................................. 67

4

Portable Bedside Capnograph/Pulse Oximeter

Chapter 9 69

Alarms and Messages 69

Introduction ................................................................................................................... 69

Alarm Display ................................................................................................................ 70

Message Priorities ......................................................................................................... 72

Alarm Delay ................................................................................................................... 72

Types of Alarms ............................................................................................................ 72

High Priority Alarms ................................................................................................................... 73

Medium Priority Alarms .............................................................................................................. 74

Advisories ................................................................................................................................... 75

Silent Advisories ......................................................................................................................... 75

Parameter Standby Mode ............................................................................................. 76

Alarm Silence ................................................................................................................ 78

Changing Alarm Limits .................................................................................................. 79

Testing Alarm Settings .................................................................................................. 80

SpO

2

Alarms and SatSeconds ...................................................................................... 80

SatSeconds Alarm Display ........................................................................................................ 81

Alarm Limits - Factory Defaults ..................................................................................... 82

Chapter 10 83

Using Trends 83

Introduction ................................................................................................................... 83

The Trend Display Screens ........................................................................................... 84

Graphical Trend Display Screen ................................................................................... 84

Graphical Trend Display............................................................................................................. 84

Using SCROLL and ZOOM ........................................................................................................ 85

Tabular Trend Display Screen ....................................................................................... 87

Choosing Trend Parameters ......................................................................................... 89

Important Notes Regarding Trend Reports ................................................................... 89

Specific Events as seen in Trend Data.......................................................................... 89

Using the Graphical Trend Screen for Monitoring Patients ........................................... 89

Printing the Trend Data ................................................................................................. 89

Clearing Trend Memory ................................................................................................. 90

Configuring Trends ........................................................................................................ 90

Event Marking Mode .................................................................................................................. 91

Trend Graphical Display............................................................................................................. 91

Trend Increment Display ............................................................................................................ 91

Chapter 11 93

Reports 93

Apnea and O

2

Desaturation Report ............................................................................... 93

Printed Report Options .................................................................................................. 97

Printed Reports ............................................................................................................. 97

Portable Bedside Capnograph/Pulse Oximeter

5

Sample Reports........................................................................................................... 101

Sample Case Reports .............................................................................................................. 101

Sample Trend Reports ............................................................................................................. 102

Chapter 12 103

Downloading Patient Data 103

Introduction ................................................................................................................. 103

Data Transfer via the USB Data Port .......................................................................... 103

USB File Naming Convention .................................................................................................. 106

Examples .................................................................................................................................. 106

USB Error Messages ............................................................................................................... 107

Reading Patient Data from Saved Capnostream Files ............................................................ 107

Data Transfer via the RS-232 Port .............................................................................. 107

Analog Data Output with Capnostream ....................................................................... 107

Nurse Call Operation ................................................................................................... 107

Types of Nurse Call Systems ...................................................................................... 108

The Nurse Call Cable ............................................................................................................... 108

Activating Nurse Call ................................................................................................................ 109

Testing Nurse Call .................................................................................................................... 109

Operation with Hospital Patient Data Systems ............................................................ 110

Operation with Nuvon VEGA Systems ........................................................................ 110

Chapter 13 111

Maintenance and Troubleshooting 111

Introduction ................................................................................................................. 111

Determining Monitor Service Hours ............................................................................. 111

CO

2

Calibration ........................................................................................................... 112

CO

2

Calibration Check ................................................................................................ 113

Calibration Check Procedure ................................................................................................... 113

Maintenance ................................................................................................................ 114

Replacing the Fuses .................................................................................................... 114

Replacing the Printer Paper Roll ................................................................................. 115

Cleaning ...................................................................................................................... 115

Troubleshooting........................................................................................................... 116

Electrical ................................................................................................................................... 116

CO

2

Problems .......................................................................................................................... 116

SpO

2

Sensor ............................................................................................................................ 117

Printer ....................................................................................................................................... 117

Nurse Call ................................................................................................................................. 118

CO

2

Calibration ........................................................................................................................ 118

Returning the Monitor .................................................................................................. 118

Technical Assistance ................................................................................................... 118

6

Portable Bedside Capnograph/Pulse Oximeter

Appendix 1 119

Institutional Settings 119

Institutional Defaults .................................................................................................... 119

Changing Institutional Defaults .................................................................................... 119

Resetting to Factory Defaults ...................................................................................... 120

Uploading or Downloading Institutional Defaults ......................................................... 120

Changing Monitor Settings .......................................................................................... 121

Alarm Limits .............................................................................................................................. 121

Alarm Delay .............................................................................................................................. 123

Trend Settings .......................................................................................................................... 123

Changing Parameters Order on the Trend Display ................................................................. 123

Events ...................................................................................................................................... 124

How to Change Event Defaults ................................................................................................ 124

Monitor Settings ....................................................................................................................... 124

CO

2

Parameters ....................................................................................................................... 126

SpO

2

Parameters ..................................................................................................................... 126

Appendix 2 127

Specifications 127

Power Supply .............................................................................................................. 127

Battery ......................................................................................................................... 127

Controls ....................................................................................................................... 127

Display ........................................................................................................................ 128

Microstream

®

Capnography ........................................................................................ 128

Nellcor Oximax

®

Pulse Oximetry ................................................................................. 129

Alarms ......................................................................................................................... 129

Outputs ........................................................................................................................ 129

Analog Output .......................................................................................................................... 129

Nurse Call ................................................................................................................................. 130

RS-232 ..................................................................................................................................... 131

USB .......................................................................................................................................... 131

Internal Thermal Printer (optional) ............................................................................... 131

General Characteristics ............................................................................................... 132

Equipment Classification ............................................................................................. 132

Compliance ................................................................................................................. 132

Electromagnetic Immunity ........................................................................................................ 132

Appendix 3 137

Microstream EtCO

2

Consumables 137

Microstream EtCO

2

Consumables............................................................................... 137

Portable Bedside Capnograph/Pulse Oximeter

7

Appendix 4 139

Capnostream Service Password 139

Capnostream Service Password ................................................................................. 139

8

Portable Bedside Capnograph/Pulse Oximeter

List of Figures

Figure 1 - Installing the Battery Pack ................................................................................................... 22

Figure 2 - Battery Pack Close-up ......................................................................................................... 22

Figure 3 - Menu Bar with Battery Charge Level ................................................................................... 23

Figure 4 - Monitor Bottom View ............................................................................................................ 25

Figure 5 - Capnostream Front View ..................................................................................................... 27

Figure 6 - Front Panel Control Buttons ................................................................................................ 28

Figure 7 - Capnostream Rear View ...................................................................................................... 29

Figure 8 - Capnostream Left View ........................................................................................................ 30

Figure 9 - Salutation Screen ................................................................................................................. 31

Figure 10 - Typical Home Screen ......................................................................................................... 32

Figure 11 - Typical Home Screen when A/hr and ODI are not Available ............................................ 33

Figure 12 - Standard Home Screen without IPI Option ....................................................................... 34

Figure 13 - Header Area ....................................................................................................................... 34

Figure 14 - Typical Numeric Home Screen .......................................................................................... 36

Figure 15 - System Setup Screen ........................................................................................................ 39

Figure 16 - Menu Bar ............................................................................................................................ 47

Figure 17 - Alarm Volume Selection..................................................................................................... 47

Figure 18 - Pulse Tone Volume Selection ............................................................................................ 47

Figure 19 - Scavenger System Connection Point ................................................................................ 48

Figure 20 - Screen Menu Reference Chart when A/hr and ODI are available .................................... 50

Figure 21 - Screen Menu Reference Chart when A/hr and ODI are not available .............................. 51

Figure 22 - CO

2

Data on the Capnostream Monitor ............................................................................. 54

Figure 23 - CO

2

Section of Numeric Home Screen ............................................................................. 55

Figure 24 - SpO

2

Data on the Capnostream Monitor - Standard Screen ............................................ 61

Figure 25 - SpO

2

Data on the Capnostream Monitor – Standard Screen with IPI Disabled ............... 61

Figure 26 - SpO

2

Section of Numeric Home Screen ............................................................................ 62

Figure 27 - IPI Trend Graph ................................................................................................................. 63

Figure 28 - Capnostream Alarm Review Screen ................................................................................. 71

Figure 29 - Example Showing Alarms .................................................................................................. 73

Figure 30 - Alarm Limits Screen ........................................................................................................... 79

Figure 31 - Graphical Trend Display .................................................................................................... 84

Figure 32 - Scroll mode in the Graphical Trend ................................................................................... 86

Figure 33 - Tabular Trend Display ........................................................................................................ 87

Figure 34 - Trend Memory Message .................................................................................................... 90

Figure 35 - Apnea and Desat Report Screen ....................................................................................... 95

Figure 36 - Apnea and Desat Printed Report ....................................................................................... 96

Figure 37 - Print Screen ....................................................................................................................... 98

Figure 38 - Sample Case Reports Printout ........................................................................................ 101

Figure 39 - Printed Trend Reports ...................................................................................................... 102

Figure 40 - Typical Flash Memory Device .......................................................................................... 104

Figure 41 - USB Icon .......................................................................................................................... 105

Figure 42 - Stereo Phono Plug for Nurse Call.................................................................................... 108

Figure 43 - Connection Point for Nurse Call ...................................................................................... 109

Figure 44 - Service Screen ................................................................................................................. 112

Figure 45 - Insert Paper Roll into printer ............................................................................................ 115

Figure 46 - Institutional Defaults Screen ............................................................................................ 120

Figure 47 - Software Support Screen ................................................................................................. 121

Figure 48 - Institutional Defaults Alarm Limits Screen ....................................................................... 122

Figure 49 - Institutional Defaults: Monitor .......................................................................................... 125

Portable Bedside Capnograph/Pulse Oximeter

9

List of Tables

Table 1 - Symbols that Appear on the Monitor .................................................................................... 16

Table 2 - Capnostream Accessories .................................................................................................... 25

Table 3 - Printer Paper Specifications .................................................................................................. 26

Table 4 - Capnostream Front View ...................................................................................................... 28

Table 5 - Capnostream Rear View ....................................................................................................... 29

Table 6 - Capnostream Left View ......................................................................................................... 30

Table 7 - Header Section ..................................................................................................................... 34

Table 8 - Event Markings ..................................................................................................................... 46

Table 9 - Audio Alarm Volume ............................................................................................................. 47

Table 10 - Adjustable CO

2

Parameters ................................................................................................ 56

Table 11 - Nellcor SpO

2

Sensors ......................................................................................................... 58

Table 12 - Adjustable SpO

2

Parameters .............................................................................................. 62

Table 13 - Adjustable IPI Options ........................................................................................................ 64

Table 14 - Alarm Indications ................................................................................................................. 69

Table 15 - High Priority Alarms ............................................................................................................ 73

Table 16 - Medium Priority Alarms ....................................................................................................... 74

Table 17 - Advisories ............................................................................................................................ 75

Table 18 - Silent Advisories .................................................................................................................. 75

Table 19 - Message and Alarm Status during Different Parameter Standby Situations ..................... 78

Table 20 - Tabular Display Example .................................................................................................... 88

Table 21 - Detailed Tabular Display Example ...................................................................................... 88

Table 22 - Monitor Parameters............................................................................................................. 90

Table 23 - Printed Reports – Parameters ............................................................................................ 98

Table 24 - Data Transfer Types ......................................................................................................... 103

Table 25 - Select Data Output Type ................................................................................................... 105

Table 26 - File Naming Conventions .................................................................................................. 106

Table 27 - Nurse Call Specs .............................................................................................................. 108

Table 28 - Nurse Call Indicators ......................................................................................................... 109

Table 29 - Factory Default Alarm/Indicator Limits .............................................................................. 122

Table 30 - Factory Default and Optional Alarm Delay Settings ......................................................... 123

Table 31 - Factory Default and Optional Trend Settings ................................................................... 123

Table 32 - Guidance and Manufacturer's Declaration - Electromagnetic Emissions ........................ 133

Table 33 - Guidance and Manufacturer’s Declaration – Electromagnetic Immunity ......................... 133

Table 34 - Recommended Separation Distances between Portable and Mobile RF

Communications Equipment and the Monitor .......................................................................... 135

10

Portable Bedside Capnograph/Pulse Oximeter

Oridion Medical 1987 Ltd. ("Oridion Medical") -

Warranty for Oridion Monitors

THIS LIMITED WARRANTY applies to any patient monitor manufactured by Oridion Medical 1987 Ltd.

(“Oridion”), (“Products”). Subject to the limitations herein, Oridion warrants that Products, when delivered by

Oridion or its authorized distributor, for two (2) years following the delivery date, but no more than 27 months

following the date of production, will be free from defects in material and workmanship and will substantially

conform to published Oridion specifications for the respective Products and in effect at the time of manufacture.

This limited warranty excludes (i) Products purchased through unauthorized third parties; (ii) Products that have

been subject to misuse, mishandling, accident, alteration, neglect, unauthorized repair or installation; and (iii)

Products that have been used with accessory consumable products other than Oridion’s FilterLine

®

products.

Furthermore, this limited warranty shall not apply to the use of Products in an application or environment that is not

within Oridion specifications or in the event of any act, error, neglect or default of Customer. Oridion at its sole

discretion will replace or repair the damaged Products. Customer may not return Products without first obtaining a

customer return material authorization (RMA) number from Oridion or one of the Authorized Service centers and a

copy of the Product purchase invoice.

Disclaimer

USER MAY USE THE PARAMETERS (INCLUDING ANY AND ALL REFERENCES TO CO2, SPO2,

CURRENT INTEGRATED PULMONARY INDEX™ AND FUTURE AND RELATED INDICES AND

CONFIGURATIONS AND SIGNAL ALARM NOTIFICATIONS) WHICH APPEAR ON ORIDION'S PATIENT

MONITORING DEVICES AND/OR ORIDION’S COMMUNICATION PROTOCOL AND/OR ANY OUTPUT

IN REPORTS DOWNLOADED FROM ORIDION'S PATIENT MONITORING DEVICES TO PRINTERS OR

USB MEMORY STICKS OR APPROVED SYSTEMS ("DATA") SOLELY AND EXCLUSIVELY FOR THE

PURPOSE OF PATIENT CARE. USER ACKNOWLEDGES THAT DATA TRANSMITTED FROM

ORIDION'S PATIENT MONITORING DEVICES MAY NOT BE TRANSFERRED, INTERFACED,

EXCHANGED OR OTHERWISE TRANSMITTED AND THAT ORIDION ACCEPTS NO RESPONSIBILITY

WHATSOEVER FOR THE ACCURACY OR COMPLETENESS OF DATA THAT HAS BEEN

TRANSFERRED, INTERFACED, EXCHANGED OR OTHERWISE TRANSMITTED. USER FURTHER

ACKNOWLEDGES THAT IT MAY NOT SELL, LICENSE OR OTHERWISE COMMERCIALIZE THE DATA,

IN WHOLE OR IN PART. ANY OTHER USE OF THE DATA OR INTERFACE WITH OTHER SYSTEMS,

WHETHER BY USER OR ANY PARTY ON ITS BEHALF, SHALL BE SUBJECT TO A SEPARATE

LICENSING ARRANGEMENT WITH ORIDION INCORPORATING, BUT NOT LIMITED TO,

COMMERCIAL TERMS TO BE NEGOTIATED IN GOOD FAITH.

USER ACKNOWLEDGES AND UNDERSTANDS THAT THE DATA IS PROVIDED “AS-IS” AND THAT

ORIDION DISCLAIMS ALL WARRANTIES, EXPRESS OR IMPLIED, INCLUDING WARRANTIES OF

MERCHANTABILITY AND FITNESS FOR A PARTICULAR PURPOSE. ORIDION WILL NOT BE LIABLE

FOR ANY INJURIES OR DAMAGES TO ANY PERSONS OR TANGIBLE OR INTANGIBLE PROPERTY

RESULTING FROM ANY CAUSE WHATSOEVER. ORIDION DISCLAIMS ANY AND ALL LIABILITY

FOR DIRECT, INDIRECT, INCIDENTAL, SPECIAL, CONSEQUENTIAL, OR OTHER SIMILAR DAMAGES

REGARDLESS OF THE FORM OF ACTION WHETHER IN CONTRACT, TORT (INCLUDING

NEGLIGENCE), STRICT PRODUCT LIABILITY OR ANY OTHER LEGAL OR EQUITABLE THEORY,

EVEN IF ORIDION HAS BEEN ADVISED OF THE POSSIBILITY OF SUCH LOSSES OR DAMAGES.

Portable Bedside Capnograph/Pulse Oximeter

11

Do not touch this field - it is invisible and does not appear in the

final document

Safety Information

Warnings

Definitions

To use the Capnostream

®

20

P

monitor (henceforth referred to as Capnostream) correctly and safely, carefully

read this operator’s manual and the Directions for Use that accompany Microstream

®

etCO

2

consumables

(FilterLines

®

, henceforth referred to as FilterLines) and the SpO

2

sensors. Use of the monitor requires full

understanding and strict observance of these instructions, the precautionary information in boldface type, and

the specifications.

Warnings

General

WARNING: If uncertain about the accuracy of any measurement, first check the patient’s vital signs by

alternate means, and then make sure the monitor is functioning correctly.

WARNING: The device should not be used as an apnea monitor.

WARNING: The device should be considered an early warning device. As a trend towards patient

deoxygenation is indicated, blood samples should be analyzed by a laboratory co-oximeter

to completely understand the patient's condition.

WARNING: To ensure patient safety, do not place the monitor in any position that might cause it to fall

on the patient.

WARNING: Carefully route patient cabling (SpO

2

sensor and FilterLine) to reduce the possibility of

patient entanglement or strangulation.

WARNING: Do not lift the monitor by the SpO

2

sensor cable or FilterLine, as they could disconnect

from the monitor, causing the monitor to fall on the patient.

WARNING: The monitor should not be used adjacent to or stacked with other equipment; if adjacent or

stacked use is necessary, the monitor shall be observed to verify normal operation in the

configuration in which it will be used.

WARNING: To ensure accurate performance and prevent device failure, do not expose the monitor to

extreme moisture, such as rain.

WARNING: The use of accessories, transducers, sensors and cables other than those specified may result

in increased emission and/or decreased immunity of the equipment and/or system.

WARNING: Re-use of single-use accessories could pose a cross-contamination risk to the patient or

damage the functioning of the monitor.

WARNING: CO

2

readings, respiratory rate, pulse oximetry readings, and pulse signals can be affected by

sensor application errors, certain ambient environmental conditions, and certain patient

conditions.

WARNING: The monitor is a prescription device and is to be operated by qualified healthcare personnel

only.

WARNING: No modification of this equipment is allowed.

Warnings

12

Portable Bedside Capnograph/Pulse Oximeter

WARNING: If calibration does not take place as instructed in the relevant service manual, the monitor

may be out of calibration. A monitor that is out of calibration may provide inaccurate

results.

Note: Devices connected to the monitor must be medical grade only.

Note: The accurate display of the following parameters is required in order to fill the essential performance of

the device: Carbon dioxide levels in expired breath (CO

2

) and respiration rate when monitoring with

capnography, and arterial oxygen saturation of blood (SpO

2

) and Pulse rate when monitoring with pulse

oximetry. If the patient is being monitored with both functions, all of these parameters will be displayed.

MRI Scanning

WARNING: Do not use oximetry sensors during magnetic resonance imaging (MRI) scanning.

Conducted current could cause burns. The sensors may affect the MRI image, and the MRI

unit may affect the accuracy of oximetry measurements.

WARNING: Do not use the FilterLine H Set Infant/Neonatal during magnetic resonance imaging (MRI)

scanning. Using the FilterLine H Set Infant/Neonatal during MRI scanning could harm the

patient.

CAUTION: During MRI scanning, the monitor must be placed outside the MRI suite. When the monitor

is used outside the MRI suite, etCO

2

monitoring can be implemented using the FilterLine

XL. (Refer to Monitoring CO2 during MRI Scanning on page 56.

CAUTION: Use of a CO

2

sampling line with H in its name (indicating that it is for use in humidified

environments) during MRI scanning may cause interference. The use of non-H sampling

lines is advised. For a list of H sampling lines, see Microstream EtCO2 Consumables on

page 137.

Monitor Use with Defibrillators

WARNING: All cables and tubing, including SpO

2

sensors and CO

2

sampling lines, should be kept clear

of the defibrillator and its electrodes, and should not run between, adjacent to, or

overlapping the electrodes and the electrode wires, in order to reduce potential interference

between the monitor and defibrillation equipment.

WARNING: All SpO

2

sensors must be completely intact and undamaged, in order to enable use of a

defibrillator with the monitor.

Alarms

WARNING: Do not silence the audible alarm if patient safety may be compromised.

WARNING: Always respond immediately to a system alarm since the patient may not be monitored

during certain alarm conditions.

WARNING: Before each use, verify that the alarm limits are appropriate for the patient being monitored.

WARNING: Check the audible alarm silence duration before temporarily silencing the audible alarms.

WARNING: Auditory alarm signal sound pressure levels which are less than ambient sound levels can

impede operator recognition of alarm conditions.

CAUTION: Setting alarm limits to extreme values may impair the alarm system’s effectiveness.

Fire Hazard

WARNING: When using the monitor with anesthetics, nitrous oxide or high concentrations of oxygen,

connect the gas outlets to a scavenger system.

WARNING: The monitor is not suitable for use in the presence of flammable anesthetic mixture with air,

oxygen or nitrous oxide.

Warnings

Portable Bedside Capnograph/Pulse Oximeter

13

WARNING: The FilterLine may ignite in the presence of O

2

when directly exposed to laser, ESU

devices, or high heat. When performing head and neck procedures involving laser,

electrosurgical devices or high heat, use with caution to prevent flammability of the

FilterLine or surrounding surgical drapes.

Electrical

WARNING: To protect against electric shock hazard, the monitor’s cover is to be removed only by

qualified service personnel. There are no user-serviceable parts inside.

WARNING: To ensure patient electrical isolation, connect only to other equipment with circuits that are

electrically isolated.

WARNING: Connect the device only to a three-wire, grounded, hospital grade receptacle. The three-

conductor plug must be inserted into a properly wired three-wire receptacle; if a three-wire

receptacle is not available, a qualified electrician must install one in accordance with the

governing electrical code. Do not under any circumstances remove the grounding connector

from the power plug. Do not use extension cords or adapters of any type. The power cord

and plug must be intact and undamaged. To avoid the risk of electric shock, this equipment

must only be connected to a supply mains with protective earth.

WARNING: Ensure that the monitor is positioned so that its mains plug is accessible for immediate

disconnection from supply mains, when needed.

WARNING: If there is any doubt about the integrity of the protective earth conductor arrangement,

operate the device on internal battery power until the AC power supply protective

conductor is fully functional.

WARNING: Do not connect to an electrical outlet controlled by a wall switch or a dimmer.

WARNING: Measure the device's leakage current whenever an external device is connected to the serial

port. Leakage current must not exceed 100 microamperes.

WARNING: To avoid risk of electric shock, this equipment must only be connected to a supply mains

with protective grounding.

WARNING: Whenever the equipotential ground at the back of the device (reference Figure 7 -

Capnostream Rear View on page 29) is to be used, the user must connect to the pin in a way

which will ensure that accidental disconnection is avoided.

WARNING: In a facility which provides detachable potential equalization conductors, the Equipotential

ground at the back of the device (reference Figure 7 - Capnostream Rear View on page 29)

may be used for optional connection between the Capnostream and the potential

equalization busbar of the electrical installation. The Equipotential ground at the back of the

device should not be used for a protective earth connection.

WARNING: Always connect power cord to the device first, and then plug the power cord into the wall

outlet.

CAUTION: Electrical installation of the room or the building in which the monitor is to be used must

comply with regulations specified by the country in which the equipment is to be used.

CAUTION: Keep power cord, plug and socket clear in case an urgent power supply disconnection is

required.

Electro-magnetic Interference

This device has been tested and found to comply with the requirements for medical devices according to the

standard EN60601-1-2. This standard is designed to provide reasonable protection against harmful interference

in a typical medical installation.

However, because of the proliferation of radio-frequency transmitting equipment and other sources of electrical

noise in healthcare environments (for example: cellular phones, mobile two–way radios, electrical appliances),

Definitions

14

Portable Bedside Capnograph/Pulse Oximeter

it is possible that high levels of such interference due to close proximity or strength of a source may result in

disruption of performance of this device.

WARNING: Operating high frequency electrosurgical equipment in the vicinity of the monitor can

produce interference in the monitor and cause incorrect measurements.

WARNING: Do not use the monitor with nuclear spin tomography (MRT, NMR, NMT) as the function

of the monitor may be disturbed.

Definitions

Note: A Note is inserted to point out procedures or conditions which may otherwise be misinterpreted or

overlooked and to clarify apparently contradictory or confusing situations.

Caution: A Caution is inserted to call attention to a procedure which, if not followed exactly, can lead to

damage or destruction of the equipment.

Warning: A Warning is inserted to call attention to dangerous or hazardous conditions inherent to the

operation, cleaning, and maintenance of the equipment which may result in personal injury or death of the

operator or patient.

Portable Bedside Capnograph/Pulse Oximeter

15

Do not touch this field - it is invisible and does not appear in the

final document

Chapter 1

About this Manual

Overview

Intended Use

Specific Indications for Use

Who Should Read This Manual

Contacting Technical Support

Symbols

Overview

This manual provides directions for setting up and operating the Capnostream monitor.

The Capnostream is a portable bedside monitor that continuously monitors a patient’s:

• End tidal carbon dioxide (etCO

2

) - level of carbon dioxide in exhaled breath.

• Respiratory rate (RR).

• Fractional inspired carbon dioxide (FiCO

2

) - level of carbon dioxide present during inhalation.

• Oxygen saturation (SpO

2

).

• Pulse rate (PR).

The device also provides an Integrated Pulmonary Index™ (henceforth referred to as IPI) value, which is a

numerical value that integrates four major parameters measured by Capnostream in order to provide a simple

indication of the patient’s ventilatory status. The integrated parameters are etCO

2

, RR, SpO

2

, and PR. Only

these four parameters are used to calculate IPI; other parameters are not taken into account.

In addition, the device provides the Apneas per Hour (A/hr) and an Oxygen Desaturation Index (ODI), used to

help in the identification and quantification of apnea and oxygen desaturation events for patients over age 22, as

follows:

• A/hr: a count of the number of pauses in breathing (of at least 10 seconds) which the patient experienced,

either over the past hour (on the Home screen) or average pauses per hour over a period of time (on the

Apnea and O

2

Desaturation screen).

• ODI: the number of times that the SpO

2

value dropped 4% or more from baseline and returned to baseline

in 240 seconds or less, either in the last hour (on the Home screen) or average pauses per hour over a

period of time (on the Apnea and O

2

Desaturation screen).

The A/hr and ODI indices are not available in all locations. In order to equip your device with the A/hr and ODI

feature, contact Capnographyinfo@covidien.com

.

Intended Use

The Capnostream

®

20

p

combined capnograph/pulse oximeter monitor and its accessories are intended to provide

professionally trained health care providers with continuous, non-invasive measurement and monitoring of

carbon dioxide concentration of the expired and inspired breath and respiration rate, and with continuous non-

invasive monitoring of functional oxygen saturation of arterial hemoglobin (SpO

2

) and pulse rate. It is intended

for use with neonatal, pediatric, and adult patients in hospitals, hospital-type facilities, and intra-hospital

transport environments.

Capnostream

®

20p is to be operated by qualified healthcare personnel only.

Specific Indications for Use

16

Portable Bedside Capnograph/Pulse Oximeter

The Capnostream

®

20

p

monitor provides the clinician with an integrated pulmonary index (IPI). The IPI is based

on four parameters provided by the monitor: end tidal carbon dioxide, respiration rate, oxygen saturation and

pulse rate. The IPI is a single index of an adult or pediatric patient's ventilatory status displayed on a scale of

1 - 10, where 10 indicates optimal pulmonary status. IPI monitoring displays a single value that represents the

patient's pulmonary parameters and alerts clinicians to changes in the patient's pulmonary status.

The IPI is an adjunct to, and is not intended to replace, vital sign monitoring.

Specific Indications for Use

An additional indication of the monitor is to provide information to help in the identification of apnea and

oxygen desaturation events in adult patients (age 22 and up) in hospital ICU and general floor environments,

through the reporting of these events and calculation of the associated apnea per hour (A/hr) and oxygen

desaturation index (ODI).

Who Should Read This Manual

This manual should be read by:

• Health Care Professionals who will be using Capnostream.

• Equipment managers responsible for ensuring that equipment conforms to institutional policies.

• Researchers or laboratory personnel who will be downloading patient data.

• Technical experts who will be connecting Capnostream to a computer via the RS-232 interface.

WARNING: In the United States, federal law restricts this device to sale by or on the order of a

physician.

Contacting Technical Support

For any technical issue involving the Capnostream monitor, please contact Oridion Technical Support, as

follows:

North America: Tel: 1-888-ORIDION (674-3466), Fax: (781) 453-2722; Outside North America:

Tel: + (972) 2-589-9104, Fax: + (972) 2-582-8868; E-mail: Capnographytechnicalsupport@covidien.com

.

Symbols

The following symbols appear on the body of the monitor.

Table 1 - Symbols that Appear on the Monitor

Symbol Description

Monitor ON/OFF button

AC power ON indicator

UNIT ON indicator

Event selection

Patient Admit/Discharge

Symbols

Portable Bedside Capnograph/Pulse Oximeter

17

Symbol Description

Pump Off

Temporarily silence alarms

Type BF Defibrillator Proof Protection

General warning sign

Gas inlet

Gas outlet

Equipotential ground

USB flash memory connection port

CE Mark

For prescription use only

Directive on waste electrical and electronic

equipment

Follow instructions for use

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Oridion Capnostream 20p User manual

Oridion Capnostream 20p User manual

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